BI 1819479 for Pulmonary Fibrosis

Recruiting in Palo Alto (17 mi)

+180 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Recruiting

Sponsor: Boehringer Ingelheim

Must be taking: Nintedanib, Pirfenidone

Must not be taking: Immunosuppressants, Prednisone

Disqualifiers: Acute IPF exacerbation, Significant disease, others

Prior Safety Data

Trial Summary

What is the purpose of this trial?This study is open to adults 40 years or older with idiopathic pulmonary fibrosis (IPF). People can join the study if they are not on any treatment for IPF are on stable treatment for at least 3 months before starting the study. The purpose of this study is to find out whether a medicine called BI 1819479 helps people with IPF. 3 different doses of BI 1819479 are tested in this study. Participants are put into 4 groups by chance. Participants in 3 groups get different doses of BI 1819479. Participants in 1 group get placebo. Placebo tablets look like BI 1819479 tablets, but do not contain any medicine. Participants take the treatment for 6 months to 1 year. Participants are in the study for up to 1 year and 2 months. During this time, they visit the study site between 10 and 12 times and get up to 11 phone calls from the site staff. At site visits doctors regularly perform breathing tests that measure how well the lungs are working. Researchers compare the results between participants who take BI 1819479 and placebo. The doctors also regularly check participants' health and take note of any unwanted effects.

Will I have to stop taking my current medications?

The trial does not specify if you must stop taking your current medications, but you need to be on stable treatment for IPF or not on treatment for at least 3 months before starting. You cannot take certain medications that might interfere with the trial.

Eligibility Criteria

Adults over 40 with idiopathic pulmonary fibrosis (IPF) can join this trial. They must have a certain level of lung function and if they're on IPF treatment, it needs to be stable for at least 3 months. Women who can have children and men whose partners can, must use effective birth control.

Inclusion Criteria

I am 40 years old or older.

I have signed the consent form for this trial.

I have been diagnosed with Idiopathic Pulmonary Fibrosis.

+5 more

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive different doses of BI 1819479 or placebo for 6 months to 1 year

6 months to 1 year

10-12 visits (in-person), up to 11 phone calls

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Participant Groups

The study tests BI 1819479's effect on lung function in IPF patients. Participants are randomly assigned to one of four groups: three different doses of the drug or a placebo, taken for up to a year with regular health checks and breathing tests.

4Treatment groups

Experimental Treatment

Placebo Group

Group I: BI 1819479 medium dose treatment groupExperimental Treatment1 Intervention

Group II: BI 1819479 low dose treatment groupExperimental Treatment1 Intervention

Group III: BI 1819479 high dose treatment groupExperimental Treatment1 Intervention

Group IV: Placebo groupPlacebo Group1 Intervention